Nasal spray to reduce covid-19 transmission

ABSTRACT

An embodiment provides a method for preventing the transmission of Covid-19, including: preparing a composition comprising an ACE2 monoclonal antibody, a vegetable oil, and a saline solution; and spraying the composition in a nasal cavity of a patient. Other aspects are described and claimed.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 63/080,735, filed on Sep. 20, 2020, and entitled “NASAL SPRAYTO PREVENT THE TRANSMISSION OF COVID-19 BETWEEN HUMANS,” the contents ofwhich are incorporated by reference herein.

FIELD

This application relates generally to a method for the reduction oftransmission of COVID-19, and, more particularly, to a nasal spray toreduce COVID-19 transmission.

BACKGROUND

Coronaviruses are a family of viruses that can cause illnesses such assevere acute respiratory syndrome (SARS) and Middle East respiratorysyndrome (MERS). A new coronavirus (Covid-19) was identified as thecause of a disease outbreak in China. The virus is presently known asthe severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Thedisease it causes is called coronavirus disease 2019 (COVID-19).

Cases of COVID-19 have been reported in multiple countries, where it hascaused a great deal of morbidity and mortality, in a worldwide pandemic.The disorder is characterized by shortness of breath, increased mucusproduction, sore throat, cough, and fever. This may necessitateadmission to a hospital, with subsequent admission to an intensive careunit for the respiratory support of the infected patient.

There is a need for the prevention or reduction in spread of COVID-19,due to the worldwide pandemic of this infection.

BRIEF SUMMARY

In summary, one embodiment provides a composition for preventing thetransmission of Covid-19, comprising: an ACE2 monoclonal antibody; avegetable oil; and a saline solution, wherein the ACE2 monoclonalantibody, the vegetable oil, and saline solution are combined into anasal sprayable version of the composition.

Another embodiment provides a method for preventing the transmission ofCovid-19, comprising: preparing a composition comprising an ACE2monoclonal antibody, a vegetable oil, and a saline solution; andspraying the composition in a nasal cavity of a patient.

A further embodiment provides a kit for preventing the transmissionCovid-19, comprising: a composition comprising, an ACE2 monoclonalantibody capable of blocking ACE2 receptors of a patient, a sesame oil,and a saline solution; and a sprayer for placing the composition in anasal cavity of the patient.

The foregoing is a summary and thus may contain simplifications,generalizations, and omissions of detail; consequently, those skilled inthe art will appreciate that the summary is illustrative only and is notintended to be in any way limiting.

For a better understanding of the embodiments, together with other andfurther features and advantages thereof, reference is made to thefollowing description, taken in conjunction with the accompanyingdrawings. The scope of the invention will be pointed out in the appendedclaims.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 illustrates an example flow diagram of a method of a nasal sprayfor reducing Covid-19 transmission.

DETAILED DESCRIPTION

It will be readily understood that the components of the embodiments, asgenerally described and illustrated in the figures herein, may bearranged and designed in a wide variety of different configurations inaddition to the described example embodiments. Thus, the following moredetailed description of the example embodiments, as represented in thefigures, is not intended to limit the scope of the embodiments, asclaimed, but is merely representative of example embodiments.

Reference throughout this specification to “one embodiment” or “anembodiment” (or the like) means that a particular feature, structure, orcharacteristic described in connection with the embodiment is includedin at least one embodiment. Thus, appearances of the phrases “in oneembodiment” or “in an embodiment” or the like in various placesthroughout this specification are not necessarily all referring to thesame embodiment.

Furthermore, the described features, structures, or characteristics maybe combined in any suitable manner in one or more embodiments. In thefollowing description, numerous specific details are provided to give athorough understanding of embodiments. One skilled in the relevant artwill recognize, however, that the various embodiments can be practicedwithout one or more of the specific details, or with other methods,components, materials, et cetera. In other instances, well-knownstructures, materials, or operations are not shown or described indetail. The following description is intended only by way of example,and simply illustrates certain example embodiments.

Covid-19 has spread worldwide and become a global pandemic. The loss oflife, suffering, and economic struggles have reached all corners of theglobe. Symptoms may manifest about 2-14 days after exposure. Thesymptoms may include fever, chills, cough, shortness of breath,difficulty breathing, fatigue, muscle/body aches, new loss oftaste/smell, sore throat, congestion, runny nose, nausea, vomiting, ordiarrhea. More severe symptoms may include trouble breathing, persistentpain/pressure in the chest, confusion, inability to wake or stay awake,or bluish lips/face. Some cases may require hospitalization and evenintensive care unit healthcare. Because of the novelty of the virus,very few tests exist that are specific for Covid-19. What is needed is amethod for the reduction of Covid-19 transmission.

Coronaviruses are a family of viruses that can cause illnesses such assevere acute respiratory syndrome (SARS) and Middle East respiratorysyndrome (MERS). A new coronavirus (Covid-19) was identified as thecause of a disease outbreak in China. The virus is known as the severeacute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease itcauses is called coronavirus disease 2019 (Covid-19).

Angiotensin-Converting Enzyme 2 (ACE2) is the main receptor forSARS-CoV-2. In the human lung, ACE2 is expressed on type I and IIalveolar epithelial cells. Men have shown a higher ACE2 level in theiralveolar cells than women. ACE2 is a member of the AngiotensinConverting Enzyme (ACE) family of dipeptidyl-carboxy-dipeptidase, ishighly homologous to ACE1. ACE2 has a high affinity to Ang II type 1 andtype 2 receptors and plays an important role in cell proliferation andhypertrophy, inflammatory response, blood pressure, and fluid balance.ACE2 is highly expressed in certain organs and tissues. In aphylogenetic analysis of 103 strains of SARS-CoV-2 from China, twodifferent types of SARS-CoV-2 were identified, designated type L(accounting for 70 percent of the strains) and type S (accounting for 30percent). The strains in L type, derived from S type, are evolutionarilymore aggressive and contagious.

SARS-CoV-2 may bind to ACE2 expressed on the nasal mucosal epithelialcell, and after about 96 hours enters human lower respiratory epithelialcells. ACE2 is abundantly expressed in the lungs. The expression of ACE2has been found to be much less in children, which may be a reason fortheir lower infectious rate. ACE2 increases in abundance as a childgrows, which is a reason that less than two percent of all individualsinfected with SARS-CoV-2 are children.

Based on the unique anatomical structure of olfactory nerves andolfactory bulb, the transmission may become a channel between the nasalepithelium and the central nervous system (CNS). Once latched onto thenasal respiratory cell receptors the SARS-CoV2 may engineer its fusionwith the cell membranes. As an intracellular mechanism the viral RNA maybe released intracellularly, followed by its translation and formationof a replication complex that produce more viral particles, which arethen packaged in the Golgi apparatus of the cell and finally released tothe intracellular space to renew its attack on other cells. SARS-CoV-2has been recovered from nasal secretions, feces, and blood, after it hasentered the blood stream via the olfactory nerve.

The clinical symptoms of SARS-CoV-2 infection vary a great deal frompatient to patient but include shortness of breath, increased mucusproduction, sore throat, cough, and fever. The virus first affects therespiratory epithelial cells and alveolar cells, followed by thedigestive system. This may necessitate admission to a hospital, withsubsequent admission to an intensive care unit for the respiratorysupport of the infected patient. Viral infections can produce, in some,an excessive immune reaction in the host labeled a Cytokine Storm, thatcauses an acute systemic inflammatory syndrome characterized by feverand multiple organ dysfunction. There is therefore a need for treatmentsto reduce Covid-19 transmission between humans. The aim of thisinvention is to prevent the initial transmission into the nasal mucosalepithelial cells, thereby preventing the entire sequence of pathology.

Accordingly, described herein is a method and composition for theprevention of transmission of Covid-19. In an embodiment, thecomposition may be a nasal spray placed in the nasal cavity of a human.The spray may require reapplication. The composition may comprise anACE2 antibody, the antibody may be monoclonal. The antibody may bindACE2 receptors in the nasal cavity and/or elsewhere in the respiratorytract. The binding of ACE2 receptors may prevent the mechanism of uptakeof the Covid-19 virus in a cell and its replication. The composition maycomprise a vegetable oil such as coconut, olive, sesame, or the like, ora combination thereof. The composition may comprise saline. Theosmolarity of the composition may be adjusted to the physiologicalosmolarity of a patient.

The illustrated example embodiments will be best understood by referenceto the figures. The following description is intended only by way ofexample, and simply illustrates certain example embodiments.

In an embodiment, a composition of matter and a method using thecomposition may be used that reduces the transmission of Covid-19between humans. The composition includes a nasal spray comprising atleast one vegetable oil, saline solution, and sufficient ACE2 antibodyfor efficacy. In an embodiment, the administering of the nasal spraycomposition may use a standard nasal spray bottle. The composition whenadministered using the method may be effective in reducing thetransmission of Covid-19 for an extended period.

In an embodiment, a composition comprises an ACE2 monoclonal antibody ina fluid. The composition may be sprayed into the nose and may block ACE2receptors. The blocking may occur for at least one hour and up to twodays. The fluid may include at least one vegetable oil and/or a salinesolution. In an embodiment, the volumetric ratios of vegetable oil andsaline solution in the fluid range from 0.1 to 10. ACE2 antibody may beadded to the fluid in a sufficient amount for efficacy to preventbinding. Preferably, the composition should be refrigerated at atemperature of 1-10° C. prior to spraying into each nostril of the nose.The method may comprise spraying the composition into each nostril andreleasing at least about 0.05 mL of the composition into each nostril.

The vegetable oil may include a hydrophobic element. The vegetable oilmay be selected from a group consisting of coconut oil, olive oil,sesame oil, and combinations thereof. Most preferably, the vegetable oilconsists essentially of sesame oil.

The saline solution comprises a solution of sodium chloride and water.The saline solution may have an osmolarity similar in osmolarity tobodily tissue. The saline solution may comprise a normal salinesolution, which is a mixture of salt and water (0.9% NaCl) and is anisotonic fluid containing water, sodium (154 mEq/L) and chloride (154mEq/L) similar in concentration to bodily fluids.

The ACE2 antibody can include a commercially produced monoclonal ACE2antibody, such as, for example, Proteintech (Proteintech, Rosemont,Ill., USA: Cat No. 66699-1-Ig). Other commercial antibodies may be used.An alternative ACE2 antibody may also be created utilizing standardlaboratory procedures well known in the art.

In embodiments, the composition includes 10-25 ml of sesame oil, atleast 5 ml of saline solution, and at least 150 μl of ACE2 antibody. Inone embodiment, the composition comprises 10 mL of sesame oil, 10 mLnormal saline solution, and 150 μl of Proteintech or other ACE2antibody. In an alternative embodiment, the composition includes 20 mlof a fluid comprising a 1:1 sesame oil: normal saline solution with upto 2000 μl of laboratory produced monoclonal ACE2 antibody.

In an embodiment, the composition may be created with a longer shelflife. A variant of the composition, for prolongation of its efficacy,utilizes monomers which form a biodegradable polymer matrix for the slowrelease of the ACE2 monoclonal antibodies into the nose. Slow-releasedrug delivery technologies are well known to one skilled in the art andinclude commercially available products such as SynBiosys® (InnoCorePharmaceuticals, Groningen, The Netherlands, a registered trademark inthe US and other countries). The technology uses several monomers toform a biodegradable polymer matrix in which monoclonal antibodiesagainst ACE2 can be entrapped. When brought into an aqueous environment,the polymers swell and gradually release the monoclonal antibodies bydiffusion. Release time can be regulated from hours up to days. TheSynBiosys® polymers may comprise DL-lactide, glycolide, ε-caprolactoneand polyethyleneglycol—biologically monomers. A SynBiosys®' feature isthat it allows sustained release of the composition over time.

Referring to FIG. 1, an example method is illustrated. In an embodiment,a method for preventing the transmission of Covid-19 may includepreparing a composition comprising an ACE2 monoclonal antibody, avegetable oil, and a saline solution at 101. In an embodiment, thecomposition may be sprayed in a nasal cavity of a patient at 102.

An exemplar embodiment has been described above. However, it will beapparent to those skilled in the art that numerous variations of thetype described could be made to the present invention without departingfrom the spirit of the invention. The scope of the present invention isdefined by the broad general meaning of the terms in which the claimsare expressed.

Unless otherwise indicated, all numbers expressing quantities ofingredients, properties such as molecular weight, reaction conditions,and so forth used in the specification and claims are to be understoodas being modified in all instances by the term “about.”

Accordingly, unless indicated to the contrary, the numerical parametersset forth in the following specification and attached claims areapproximations that may vary depending upon the desired propertiessought to be obtained by the present invention. At the very least, andnot as an attempt to limit the application of the doctrine ofequivalents to the scope of the claims, each numerical parameter shouldat least be construed in light of the number of reported significantdigits and by applying ordinary rounding techniques.

While the invention has been particularly shown and described withreference to a preferred embodiment, it will be understood by thoseskilled in the art that various changes in form and detail may be madetherein without departing from the spirit and scope of the invention.All documents, books, manuals, papers, patents, published patentapplications, guides, abstracts, and other references cited herein areincorporated by reference in their entirety.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with the true scope and spiritof the invention being indicated by the following claims.

It can be appreciated from the foregoing that electronic components ofone or more systems or devices may include, but are not limited to, atleast one processing unit, a memory, and a communication bus orcommunication means that couples various components including the memoryto the processing unit(s). A system or device may include or have accessto a variety of device readable media. System memory may include devicereadable storage media in the form of volatile and/or nonvolatile memorysuch as read only memory (ROM) and/or random access memory (RAM). By wayof example, and not limitation, system memory may also include anoperating system, application programs, other program modules, andprogram data.

Embodiments may be implemented as an instrument, system, method orprogram product. Accordingly, an embodiment may take the form of anentirely hardware embodiment, or an embodiment including software(including firmware, resident software, micro-code, etc.) that may allgenerally be referred to herein as a “circuit,” “module” or “system.”Furthermore, embodiments may take the form of a program product embodiedin at least one device readable medium having device readable programcode embodied thereon.

A combination of device readable storage medium(s) may be utilized. Inthe context of this document, a device readable storage medium (“storagemedium”) may be any tangible, non-signal medium that can contain orstore a program comprised of program code configured for use by or inconnection with an instruction execution system, apparatus, or device.For the purpose of this disclosure, a storage medium or device is to beconstrued as non-transitory, i.e., not inclusive of signals orpropagating media.

Program code for carrying out operations may be written in anycombination of one or more programming languages. The program code mayexecute entirely on a single device, partly on a single device, as astand-alone software package, partly on single device and partly onanother device, or entirely on the other device. In some cases, thedevices may be connected through any type of connection or network,including a local area network (LAN) or a wide area network (WAN), orthe connection may be made through other devices (for example, throughthe Internet using an Internet Service Provider), through wirelessconnections, e.g., near-field communication, or through a hard wireconnection, such as over a USB connection.

Example embodiments are described herein with reference to the figures,which illustrate example methods, devices and products according tovarious example embodiments. It will be understood that the actions andfunctionality may be implemented at least in part by programinstructions. These program instructions may be provided to a processorof a device, e.g., a hand-held measurement device, or other programmabledata processing device to produce a machine, such that the instructions,which execute via a processor of the device, implement thefunctions/acts specified.

It is noted that the values provided herein are to be construed toinclude equivalent values as indicated by use of the term “about.” Theequivalent values will be evident to those having ordinary skill in theart, but at the least include values obtained by ordinary rounding ofthe last significant digit.

This disclosure has been presented for purposes of illustration anddescription but is not intended to be exhaustive or limiting. Manymodifications and variations will be apparent to those of ordinary skillin the art. The example embodiments were chosen and described in orderto explain principles and practical application, and to enable others ofordinary skill in the art to understand the disclosure for variousembodiments with various modifications as are suited to the particularuse contemplated.

Thus, although illustrative example embodiments have been describedherein with reference to the accompanying figures, it is to beunderstood that this description is not limiting and that various otherchanges and modifications may be affected therein by one skilled in theart without departing from the scope or spirit of the disclosure.

What is claimed is:
 1. A composition for preventing the transmission ofCovid-19, comprising: an ACE2 monoclonal antibody; a vegetable oil; anda saline solution, wherein the ACE2 monoclonal antibody, the vegetableoil, and saline solution are combined into a nasal sprayable version ofthe composition.
 2. The composition of claim 1, wherein the vegetableoil is selected from the group consisting of coconut oil, olive oil, andsesame oil.
 3. The composition of claim 1, further comprising storingthe composition at a temperature of 1-10 degrees Celsius.
 4. Thecomposition of claim 1, further comprising adding at least one monomerto form a biodegradable polymer matrix.
 5. The composition of claim 1,wherein the saline adjusts the osmolarity of the composition to besimilar to the osmolarity of a patient.
 6. The composition of claim 1,wherein the saline comprises 0.9% sodium chloride.
 7. The composition ofclaim 1, wherein a volumetric ratio of the vegetable oil and the salinesolution range from 0.1 to
 10. 8. The composition of claim 1, wherein aconcentration of the ACE2 monoclonal antibody is adjusted for a bindingefficiency.
 9. The composition of claim 1, wherein the ACE2 monoclonalantibody blocks ACE2 receptors of a patient.
 10. The composition ofclaim 1, further comprising spraying the composition into a nasal cavityof a patient.
 11. A method for preventing the transmission of Covid-19,comprising: preparing a composition comprising an ACE2 monoclonalantibody, a vegetable oil, and a saline solution; and spraying thecomposition in a nasal cavity of a patient.
 12. The method of claim 11,wherein the vegetable oil is selected from the group consisting ofcoconut oil, olive oil, and sesame oil.
 13. The method of claim 11,further comprising storing the composition at a temperature of 1-10degrees Celsius.
 14. The method of claim 11, further comprising addingat least one monomer to form a biodegradable polymer matrix.
 15. Themethod of claim 11, wherein the saline adjusts the osmolarity of thecomposition to be similar to the osmolarity of a patient.
 16. The methodof claim 11, wherein the saline comprises 0.9% sodium chloride.
 17. Themethod of claim 11, wherein a volumetric ratio of the vegetable oil andthe saline solution range from 0.1 to
 10. 18. The method of claim 11,wherein a concentration of the ACE2 monoclonal antibody is adjusted fora binding efficiency.
 19. The method of claim 11, wherein the ACE2monoclonal antibody blocks ACE2 receptors of a patient.
 20. A kit forpreventing the transmission Covid-19, comprising: a compositioncomprising, an ACE2 monoclonal antibody capable of blocking ACE2receptors of a patient, a sesame oil, and a saline solution; and asprayer for placing the composition in a nasal cavity of the patient.